Latest news with #MDSAP
Toronto Star
22-07-2025
- Health
- Toronto Star
Health Canada Authorizes bioLytical's iStatis Syphilis Test, Boosting Rapid Response to Rising Infections in Canada
Now authorized for professional use in Canada, the iStatis Syphilis Antibody Test offers a fast, accurate, and portable solution to strengthen syphilis screening efforts nationwide. Health Canada authorizes the iStatis Syphilis Antibody Test for professional use, delivering reliable results in under 15 minutes Enables rapid, accurate screening in both clinics and outreach programs Backed by bioLytical's MDSAP: ISO 13485:2016-certified quality system, with high sensitivity and specificity
Yahoo
05-06-2025
- Business
- Yahoo
AMDI Completes Clinical Study for Sub 10-minute Fast PCR System and Secures MDSAP Certification
SANTA ANA, Calif., June 5, 2025 /PRNewswire/ -- Autonomous Medical Devices Incorporated (AMDI), a developer of ultrafast PCR-based diagnostics, announced today the successful completion of its multicenter clinical study supporting FDA submission of its Mini Respiratory Panel. The respiratory panel is the first test developed for its Fast PCR system. In parallel, the company has obtained certification under the Medical Device Single Audit Program (MDSAP), a globally recognized framework for compliance with international quality and safety standards. The Mini Respiratory Panel multicenter clinical study enrolled over 1,900 subjects to evaluate the performance of its ability to detect 4 of the most common respiratory pathogens: Flu A, Flu B, SARS-CoV-2 and RSV. The Fast PCR system is designed for CLIA-waived environments and delivers gold-standard RT-PCR results at the time of care: under 10 minutes. "This dual achievement—completing our clinical study and earning MDSAP certification—represents significant progress on the commercial strategy for the company," said Dave Okrongly, Chief Executive Officer of AMDI. "It's a testament to the AMDI Team, the robustness of our technology, and the quality of the partnerships we have established. We are very excited about the clinical results and remain laser-focused on accelerating access to high-performance diagnostics at the time of care." MDSAP certification, which is accepted by regulators in the United States, Canada, Brazil, Australia, and Japan, demonstrates that AMDI's quality management systems meet the stringent standards required for global market access. The certification was awarded following a comprehensive audit of AMDI's quality management processes, development and manufacturing operations. "Achieving MDSAP certification affirms that AMDI's quality systems meet the highest international benchmarks," stated Aiying Sun, EVP of Quality, Regulatory & Clinical Affairs. "It reinforces our commitment to global compliance and positions us for streamlined regulatory engagement across key markets." AMDI will submit its dual 510(k) and CLIA Waiver application for the Fast PCR system in the 3rd quarter of 2025. The Fast PCR system is the beginning of AMDI's broader vision to deliver rapid, reliable, and scalable molecular testing solutions for infectious diseases and other pressing diagnostic needs. AMDI Media Contact: Brian Millermedia@ View original content to download multimedia: SOURCE Autonomous Medical Devices Incorporated Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
16-04-2025
- Business
- Associated Press
Avant Technologies and JV Partner, Ainnova, Accelerate Expansion Across Latin America Following Key Role at Healthcare Innovation Summit
LAS VEGAS, NV / ACCESS Newswire / April 16, 2025 / Avant Technologies Inc. (OTCQB:AVAI) ('Avant' or the 'Company'), and its partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced that following Ainnova's sponsorship and its CEO's key role at the 2025 Healthcare Innovation Summit in Mexico City, both Avant and Ainnova, through their joint venture, Ai-nova Acquisition Corp. (AAC), are building on Ainnova's strong presence in Mexico by expanding its footprint across Latin America. Ainnova has initiated its first commercial pilots in both Chile and the Dominican Republic to work directly with prestigious hospitals that cover the full spectrum of care - from primary to highly specialized services. These pilot programs aim to demonstrate, (i) cost reduction in preventive diagnostics; (ii) increased efficiency in medical resource allocation and patient flow; (iii) enhanced institutional reputation driven by technological innovation; and (iv) improved profitability for participating healthcare centers through optimized patient referrals. The pilot programs leverage Ainnova's proprietary Vision AI platform to identify health risks in real time, which enable seamless referrals for specialty care or further diagnostic tests when a positive risk is detected. The broader vision for the joint venture involves deploying an automated, low-cost retinal imaging device integrated with its AI-driven platform to deliver comprehensive preventive risk screening. From just two retinal images, blood pressure and some lab test information, the system will assess risks for: cardiovascular disease (CVD), type 2 diabetes, liver fibrosis, and chronic kidney disease (CKD). The message that Ainnova's CEO, Vinicio Vargas, continues to convey to audiences around the world is that this accessible, fast, and scalable solution is designed to support early intervention and targeted treatment strategies, with the ambition of reaching millions of patients globally in the coming years. Avant has partnered with Ainnova to form AAC so the two companies can advance and commercialize Ainnova's technology portfolio worldwide. AAC has the global licensing rights for the portfolio, including its Vision AI platform and its versatile retinal cameras. Avant and Ainnova have identified Brazil and the United States as key strategic markets. Ainnova is currently addressing regulatory pathways in Brazil with the support of its MDSAP certification to meet ANVISA requirements, paving the way for rapid market entry. At the same time, Ainnova is advancing its regulatory roadmap for the U. S. The objective is to begin clinical trials in the coming months to obtain FDA approval and commercialize its technology in the U.S. - initially targeting markets where reimbursement codes for diabetic retinopathy are already approved. About Ainnova Tech, Inc. Ainnova is a Nevada-based healthtech startup with headquarters in San Jose, Costa Rica, and Houston, Texas. Founded by an experienced and innovative team that is dedicated to leveraging artificial intelligence for early disease detection. Recognized with multiple global awards and renowned partnerships with hospitals and medical device companies, we proudly introduce VisionAI - our cutting-edge platform designed to prevent blindness and detect the early onset of diabetes. Explore how Ainnova is revolutionizing healthcare through advanced technology and proactive solutions. About Avant Technologies Inc. Avant Technologies, Inc. is an emerging technology company developing solutions in artificial intelligence in healthcare. With a focus on pushing the boundaries of what is possible in AI and machine learning, Avant serves a diverse range of industries, driving progress and efficiency through state-of-the-art technology. More information about Avant can be found at You can also follow us on social media at: Forward-Looking Statements Certain statements contained in this press release may constitute 'forward-looking statements.' Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website ( In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company's ability to raise capital on acceptable terms, if at all, the Company's successful development of its products and the integration into its existing products and the commercial acceptance of the Company's products. The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date after the date of the press release. Contact: Avant Technologies, Inc. [email protected] SOURCE: Avant Technologies, Inc. press release
